From what I understand MNTA filed the necessary data in May and does not see this to be an impediment to approval.
Based upon what? There is virtually no chance that the FDA will change long standing generic approval processes. A copy of a paper document works and so does a generic drug last time i checked
Will the generic companies finally be forced to do long time trials. Looking like it might be so.
New gene expression to sway FDA and public sentiment? Will it work?-seams to keep FDA approval at bay for now
Based on a recent Zacks writeup (8/29/14) ("Momenta expects the generic version of Copaxone to be available in the first quarter of 2017") why would they tie up inventory assets for such a long period?
Management thinks this will give clearer view of their potential, which it might then lead to a better response for any secondary offering IMO Supreme court review in October might be small catalyst.. If their science is so good and through can shareholders expect a minimum of six years FDA review of any future ANDA's?
Well. Damn hate being right. Same drivel of working with FDA , Copaxone generic looks to go all the way till October for the supreme court and then still no FDA approval. They are starting trials with Baxter for their lead product. Guess Baxter saw the problem they are having with Copaxone candidate. And they are dropping an Oncology program.. Waiting till October to revisit any potential increase. Good news is they still have enough cash not to push thru a secondary offering, and if they get approval any time this year they will not do one.
If they have to do patient trials , this will drop big.
Of course it it - if the generic Copax had already been approved, MNTA's stock price would be at 20 & TEVA would have lost 20 points. Hey Shortie, that what you could be looking at ... Teva losing 20 points - how is them apples?
We will hear the same drivel "working with the FDA'. Cutting other programs cuz no relief in sight. Unless they have to now do patient trials.
weeks or months to wait - not a big deal. I'll be happy if it happens before EOY. Still plenty of money to be made by/on MNTA. ...
Wow - you think the government cares how much the taxpayers lose. The CP has to be thoroughly vetted given it is the first in the new biosimilar gene game. Thus it will be months before any approval which will go to Momenta for an at risk launch for the exclusivity period.
While it must respond within 180 days, the FDA does not have to respond to a citizen petition before it rules on a related ANDA. 7 The FDA’s policy is to assess a citizen petition prior to approving a related ANDA, but the agency does not always issue its formal response to the petition before ruling on the ANDA.
Wrong CP has ZERO impact on approval US taxpayers are losing tens of millions every delay due to this frivolous actions of TEVA and the stall tactics
No way- with the new CP just filed it will be months for all parties to put their input together for the FDA to say it gave everyone reasonable consideration.
Its called Greening. Keep on extending your 7 year licence to infinity. They have to thank the USA for the over abundance of Lawyers and legalese that has permeated the medical world. Reformation is now impossible.!